The invention relates to a system for querying, storing, retrieving and delivering digital data and images, and more particularly, to a device and method for communicating the storage and retrieval transactions between the system and participating institutions and sites.
A variety of systems have been developed for storing and retrieving digital data and images. With the advent of digital imaging and Picture Archiving and Communication Systems (PACS), the digital storage of medical images and data is becoming the norm. At the heart of all of this is the archive, the proper performance of which is key to the overall success of a PACS deployment. Much like the more traditional film library, the digital archive""s essential function is to store, identify and protect image dataxe2x80x94but with more versatility, like decreased costs, robust security and the long-term maintenance of data integrity.
In addition, hospitals, imaging centers, radiology departments and physician group practices throughout the country are exploring new technological tools in order to reduce xe2x80x9cwait timexe2x80x9d between diagnosis and treatment. Many institutions are looking towards film-less storage media as a means of improving efficiency, as well as, providing cost-effective solutions that address many of these demands.
The transition to film-less storage in the near future will allow all patient medical data, including radiological images, to be available instantly from any hospital workstation. This new digital world will enhance patient care, increased convenience, improve treatment cost-effectiveness and transform radiology processes.
Recent and upcoming legislation has forced the medical industry to move towards developing and implementing stricter standards dealing with the security of computer-based patient records. These standards require both data management and disaster recovery systems. In addition, many other industry and technologic forces are driving the need to streamline data processes and management capabilities.
The Digital Imaging and Communications in Medicine (DICOM) standard, developed by The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA), seeks to standardize the transferring of medical images and information between electronic devices by interconnecting medical imaging equipment and devices on computing networks. DICOM was initially developed to support interoperability and connectivity in radiology; however, the DICOM standard also supports many other modalities including ultrasound, X-ray and radiotherapy. DICOM supports the creation of files on removable media (such as optical disks or high-capacity magnetic tape), data structures for X-ray angiography and extended hard copy print management. The goal of DICOM is open architecture, which permits users to integrate imaging equipment from different manufacturers to support a range of modalities, as well as computer-radiography and digitized film radiographs.
Hospitals and radiology centers will sooner or later be faced with the need to transition from film-based technology to digital imaging, all while maintaining productivity in order to stay competitive in today""s healthcare environment. Advances in technology, such as DVD storage, provides a method to store and access medical and radiological images.
The major legal force behind the need to transform the way the medical industry handles digital patient records is The Health Insurance Portability and Accountability Act of 1996 (HIPAA). This act mandates that standards be established to govern the privacy of electronically stored and transmitted health information. The basis behind the proposed rules is the need to assure patients that the confidentiality and privacy of healthcare information collected, maintained, used or transmitted electronically is secure. In carrying out this task, HIPAA requires that all healthcare organizations that maintain or transmit health information electronically establish and maintain reasonable and appropriate administrative, technical and physical safeguards to ensure the integrity, confidentiality and availability of the information. These safeguards must also protect the information against any reasonably anticipated threats or hazards to its security or integrity and protect it against unauthorized use or disclosure.
Measures must include:
Administrative procedures to guard data integrity, confidentiality and availability;
A contingency plan for responding to a system emergency, wherein the data backup plan should include a method for the retrieval of exact copies of information for a specific period of time, as well as, a process enabling an enterprise to restore any loss of data in the event of fire, natural disaster, vandalism or system failure; and
Physical safeguards to guard data integrity, confidentiality and availability, including the protection of the physical computer system and related buildings.
In addition to the legal forces, demand for digital imaging is being driven by many industry factors. A few of the industry forces behind the digital movement are the desire to streamline; increase storage capacities; eliminate cine film; improve patient care; and enhance productivity by reducing image development, review and retrieval time.
Many hospitals and medical groups throughout the U.S. are storing medical information, including images, in a form that many consider xe2x80x9cprimitivexe2x80x9d. Nearly 90% of healthcare information is still stored on paper, and film is the predominant storage medium in radiology. Files in some institutions exist only in their original film form and are stored in remote locations. For older data, they may need to physically retrieve a case study from an off-site storage location, taking hours or even days. This age-old, inefficient process not only takes days to complete, but results in high storage costs and hampers quick diagnosis and intervention.
It is obvious that these facilities are faced with the need to modernize their processes and equipment. In fact, the rapid shift toward film-less digital radiology presents a growing need for hospitals and medical groups to modernize their entire radiological systems. This decision is being defined by the need to stay competitive, work more efficiently and provide state-of-the-art technology. But while the motivation is compelling, the transition to digital imaging is a difficult task requiring expensive equipment, management and training at a time when hospitals are faced with mounting pressure to increase efficiency and lower costs.
To keep up with changing technologies and to meet the storage needs that these files require, hospitals will need to either upgrade their current systems or change technologies completely. The systems and media needed to store the magnitude of data digital files require can be costly, especially over time. Tape storage systems can be upwards of $100,000 not including $150 per tape, plus the time required to manage the system. In addition, expanding the system over time results in costly upgrades for additional hardware.
With a limited number of options, the adoption of digital imaging technology within a hospital""s radiology department has tended to focus on an enterprise-wide PACS solutionxe2x80x94an information system that may include or interface to a Radiology Information System (RIS) and/or Hospital Information System (HIS). While a PACS reduces the costs of film-based imaging, the biggest challenge is the economical storage and archiving of data, which requires intensive internal management and can strain hospital IT resources.
The transition from film to digital imaging within the medical community is still in its early stages. Radiology departments are confronted with the need to convert to film-less technology in order to stay current with new diagnostic technologies, curb costs and stay competitive.
A film-less approach should mean both short-and long-term gains in quality and visualization without compromising image quality. Unlike film, digital image deterioration is less likely to occur over time with the use of a medium such as DVD or its equivalent. This will guaranty long-term gains.
The trend toward large PACS purchases by hospitals and imaging centers has recently been replaced by a digital conversion strategy that focuses on the acquisition of selected components of the system. This xe2x80x9cmini-PACSxe2x80x9d model relies on finding cost savings by xe2x80x9cunbundlingxe2x80x9d the end-to-end product-driven proposal (with its disproportionate markups) and purchasing only those components that offer the radiology department the functionality that is needed.
Using this approach, it can be very beneficial to lease certain specialized services, such as long-term digital storage, on an as-needed basis. The invention offers an alternative to the digital image storage and retrieval component of an overall PACS with a specified term service contract. The open architecture that this model employs removes the burden of archival management from the extensive list of a facility""s responsibilities. Both staff and financial resources can be freed up to focus on the department""s primary missionxe2x80x94providing high quality clinical diagnostics.
This strategy provides hospitals with a solution that both maximizes capital and increases efficiency in the management of digital medical images. Thus, the medical facility can effectively address the challenge of increasing efficiency while decreasing expenditures. As a highly specialized and adaptable DICOM storage and retrieval warehouse, the invented solution provides speed, quality, security, flexibility, scalability, cost savings and expandability appropriate to each facility""s needs.
Specifically, it enables hospitals to cost-effectively outsource the warehousing, storage and access of digital radiological images, allowing medical facilities to implement greater flexibility in budgeting procedures, so that needed capital can be redirected to areas key to quality patient care. By contracting for the archiving component separately, hospitals can save up to 30% of a PACS costxe2x80x94not to mention future costs of upgrades, technical support and compliance with the newly defined confidentiality and privacy laws (DICOM and HIPAA).
Designed to optimize the storage and archiving of DICOM images for hospitals entering the new film-less digital medical imaging age, the invention offers service for both online and near line storage and access and offline archiving of DICOM images. The invention provides archiving and retrieval sessions with an offsite digital network where electronically protected digital images can be received xe2x80x9con demandxe2x80x9d over the Internet, via a Virtual Private Network (VPN), or dedicated lines. All digital images are replicated, archived and stored at a third location offsite in warehouses. The additional layer of off-site redundancy also helps hospitals implement the legislative mandates to plan for disaster recovery.
The present invention provides a truly unique, scalable and affordably priced method for DICOM image storage managementxe2x80x94and allows the invention to provide a solution that is faster, more secure and more cost-effective than a hospital could achieve on its own. Many off-the-shelf databases considered for in-house systems are neither efficient nor fast enough to handle large DICOM objects. Secondly, economies of scale are applied to amortize the advanced technology and resources required for the storage and archiving components including communications bandwidth, storage media, software and hardware, human and technical resources and system maintenance. Also, because of the physical nature of film, storage facilities today must be located in close proximity to the hospital site. Off-site and redundant storage of electronic media entails extra costs for personnel equipment and physical space. The invention""s digital warehouses, RAID and DVD OR ITS EQUIVALENT systems design provides fail-safe disaster recovery and 24xc3x977 monitoring in case of loss or failure of onsite images. Facility archives can grow with its department""s conversion to PACS and increased use of digital modalities. With terabytes of virtual space, storage costs are controlled because customers are only buying the storage and archiving capacity they need at the time.
Permanent hardware purchases are expensive and prone to being overwhelmed by volume demands and obsolescence, particularly when dealing with the highly specialized requirements such as digital image storage. Given its reliance on sophisticated security layers, firewalls, bandwidth and technical support, closed-ended archival hardware is also expensive to staff and maintain. The invention provides an alternative solution to storage hardware ownership which is both sensible and cost effective.
Accordingly, it is the object of the invention to provide a communications, storage, retrieval and delivery device and method for use by participants which improves the speed, reliability and functionality of digital data and image storage, retrieval and delivery transactions.
Another object of the invention is to provide a communication device and method of the above character which is compatible with a plurality of radiology modalities, PACS, HIS, RIS, and compatible with DICOM standards.
Still another object of the invention is to provide a communication device and method of the above character which is compatible with HIPAA, and other Federal and State laws and regulations relating to medical patient record privacy and security standards.
A further object of the invention is to provide a communication device and method of the above character including one or more databases which are automatically accessed by a communication device.
Yet another object of the invention is to provide a communication device and method of the above character for automatically transmitting query, storage, retrieval, and delivery instructions from participant institutions.
Still a further object of the invention is to provide a communication device and method of the above character for automatically transmitting query, storage, retrieval, and delivery instructions to participant institutions.
Yet still another object of the invention is to provide a communication device and method of the above character where security control software is programmed to limit accessibility to the system.
Still a further object of the invention is to provide a communication device and method of the above character having software for remote monitoring of system devices and for updating device software and security control software.
Still another object of the invention is to provide a communication device and method of the above character where the system devices have access to the World Wide Web.
Still another object of the invention is to provide a communication device and method of the above character in which current and archived data and images are searchable by users at shared-access or remote locations.
Yet another object of the invention is to provide a communication device and method permitting real time access to stored or archived data and images from remote locations.
Yet another object of the invention is to provide a communication device and method of the above character permitting the tracking and reporting of participant transactions.
Still a further object of the invention is to provide a communication device and method of the above character for automatically applying digital signatures or message digests to transactions transmitted by participant institutions to the system devices.
These and other objects of the invention are achieved by provision of a digital data and image storage, retrieval and delivery communication device comprising a series of computer servers, storage devices and one or more databases for storing a plurality of query, storage, search and delivery information or instructions sets, a database receiver for receiving an identifier, a database searcher for searching the database, and a database transmitter for transmitting the retrieved instruction set corresponding to the identifier. The database preferably also includes a message generator for notifying participants of changes to the database.
The storage, retrieval and delivery communication device also includes a participant computer server transmitter device for communicating with the system devices located at the database storage facility. This device contains both a transmitter and receiver for receiving and outputting the retrieved, transmitted delivery instruction set and digital data and images. Most preferably, the communication delivery device are both receiver-transmitters for performing each other""s functions and comprise input units for adding and changing delivery instruction sets on the database. The system communication device is more preferably an n-customer to 1 server (client/server) system. Each customer node is connected via a communications link (Internet, VPN, VAN, dialup, etc.) to the main database server system. This provides for independent customers and servers, and thus provides for the ability of both systems to work independently. The participant computer server transmitter device acts as a transaction cache and delivery device from participant medical devices and modalities, and provides communications between the participant and the database system computer server.
The one or more databases preferably also include a plurality of account information sets, which include participant storage delivery instruction sets specified by participant institution.
In other aspects, the invention comprises methods of operating the database or databases and the query, storage, retrieval and delivery communication devices. The invention and its particular features and advantages will become more apparent from the following detailed description considered with reference to the accompanying drawings.